IsLeaf Satin Lip and Cheek Duo Berry Red: Package Insert and Label Information

ISLEAF SATIN LIP AND CHEEK DUO BERRY RED- dimethicone liquid
C3 Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

dimethicone

wter butylene glycol, beeswax, etc

for a gradient effect

keep out of reach of the children

For a gradient effect, apply only at the center and use the side of the cushion applicator to smudge the color outward to the corners of your mouth.

For cheeks, dot on cheeks and lightly smooth dotting by fingertip or applicator

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other skin irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight
2. Do not use on open wounds, eczema, and other skin irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

for external use only

ISLEAF SATIN LIP AND CHEEK DUO BERRY RED dimethicone liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70818-004 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (DIMETHICONE) DIMETHICONE 0.15 g in 100 g

Inactive Ingredients Ingredient Name Strength WATER LAURYL ALCOHOL BUTYLENE GLYCOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70818-004-01 4.5 g in 1 APPLICATOR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/08/2017

Labeler — C3 Co., Ltd. (689846633)

Registrant — C3 Co., Ltd. (689846633)

Establishment
Name	Address	ID/FEI	Operations
C3 Co., Ltd.		689846633	label (70818-004), manufacture (70818-004), pack (70818-004)

Revised: 08/2017 C3 Co., Ltd.